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RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neu...

FDA Recall #Z-0773-2023 — Class I — November 24, 2022

Recall #Z-0773-2023 Date: November 24, 2022 Classification: Class I Status: Terminated

Product Description

RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.

Reason for Recall

Complaints of leaking packets were received.

Recalling Firm

Emergent Protective Products USA Inc — Hattiesburg, MS

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

4000 units

Distribution

Distribution to US state of VA (distributor), Canada, and Switzerland

Code Information

UDI-DI: 00817129020013, Lot numbers: 23005060, 23005061, 23005062. (01)00817129020013 (10) 23005060 (17) 270718 (F5408ENG)

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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